CClinicalTrials.gg
RecruitingNCT06001918stAAAbleUpdated Sep 28, 2026

Nectero EAST System Clinical Study

A Phase 2/3 interventional study of Nectero EAST System in Abdominal Aortic Aneurysm, sponsored by Nectero Medical, Inc.. Recruiting at 42 sites in 3 countries. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Nectero Medical, Inc. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Updated Sep 28, 2026Site recruiting status changed3 sites addedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
21 Years to 85 Years
Sex
All
01

Study summary

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

02

Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • Abdominal Aortic Aneurysm
03

In context

Aortic Aneurysm, Abdominal

473 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 100 are open to participants now.

This study's planned enrollment of 400 is above the median of 66 across 233 interventional studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Nectero Medical, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).
  2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.
  3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).
  4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.
  5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.
  6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.
  7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.
  8. Subject has > three-year life expectancy.
  9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws.

Exclusion criteria

Exclusion Criteria:

  1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.
  2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.
  3. Subject has a mycotic or infected aneurysm.
  4. Subject has current vascular injury due to trauma.
  5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.
  6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.
  7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon/investigator, could result in embolization of the thrombus.
  8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.
  9. Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure.
  10. Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention.
  11. Subject has undergone other major surgery within the 30 days prior to enrollment.
  12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.
  13. Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and/or pentagalloylglucose (PGG).
  14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
  15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).
  16. Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.
  17. Subject has active systemic infection.
  18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).
  19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.
  20. Subject has dialysis dependent renal failure or baseline serum creatinine level >2.5mg/dL or eGFR \< 45 mL/min/1.73m2.
  21. Subjects with aminotransferase (ALT and/or AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory.
  22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.
  23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.
  24. Subjects with saccular AAA.
  25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.
  26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.
  27. Subjects with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR >3 for a subject on anti-coagulant therapy.
  28. Subjects with active/acute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases.
  29. Subjects with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and/or steatosis grade of S3).
  30. Subjects with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men.
  31. Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Treatment Arm

    Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer

    Drug: Nectero EAST System

  • No intervention
    Control Arm

    Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

Interventions

  • DrugNectero EAST System

    Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.

06

What researchers measure

Primary outcomes

  1. Primary Endpoint

    The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).

    Time frame: 24 months

Secondary outcomes

  1. Growth

    The growth over time in aneurysm diameter based on CT core laboratory readings.

    Time frame: 24 months

07

Study locations

38 of 42 sites recruiting
  • Honor Health Scottsdale Shea Medical Center
    Scottsdale, Arizona 85258, United States
    • HonorHealth Cardiovascular Research · Contact · 480-323-1046
    • Hasan Aldailami, MD · Principal investigator
    Recruiting
  • University of Colorado
    Aurora, Colorado 80045, United States
    Active, not recruiting
  • Medstar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Prime Vascular Institute
    Delray Beach, Florida 33446, United States
    Recruiting
  • Medical College of Georgia
    Augusta, Georgia 30912, United States
    Recruiting
  • University of Chicago
    Chicago, Illinois 60637, United States
    Recruiting
  • Ascension Alexian Brothers
    Elk Grove, Illinois 60007, United States
    • Jack Chamberlin, MD · Principal investigator
    Not yet recruiting
  • MaineMed Vascular Surgery
    Scarborough, Maine 04074, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Recruiting
  • University of Massachusetts
    Worcester, Massachusetts 01655, United States
    Recruiting
  • Beaumont Health
    Royal Oak, Michigan 48073, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Briana K Langrehr, BSN · Contact · briana.l@wustl.edu
    • Luis Sanchez, MD · Principal investigator
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
    Recruiting
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03766, United States
    Recruiting
  • University of Rochester
    Rochester, New York 14642, United States
    Recruiting
  • Stony Brook Medicine
    Stony Brook, New York 11794, United States
    Not yet recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    • Ellen Burkett · Contact · ellen.jones@duke.edu · (919)681-1878
    • Chandler Long, MD · Principal investigator
    Recruiting
  • The Christ Hospital
    Cincinnati, Ohio 45219, United States
    Recruiting
  • University Hospitals Cleveland
    Cleveland, Ohio 44106, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
    • Laurie Ann Moennich · Contact · MOENNIL@ccf.org
    • Francis Caputo, MD · Principal investigator
    Recruiting
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
    Recruiting
  • Ohio Health Riverside
    Columbus, Ohio 43214, United States
    Recruiting
  • Oklahoma Heart Institute
    Tulsa, Oklahoma 74104, United States
    Recruiting
  • Portland VA Medical Center
    Portland, Oregon 97239, United States
    Recruiting
  • St. Luke's University Health Network
    Bethlehem, Pennsylvania 18015, United States
    Recruiting
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Jefferson Clinical Research Institute
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15219, United States
    Recruiting
  • Prisma Health
    Greenville, South Carolina 29605, United States
    Recruiting
  • North Central Heart - A Division of Avera Heart Hospital
    Sioux Falls, South Dakota 57108, United States
    • Patty Eisenbraun, RN · Contact · peisenbraun@ncheart.com · 605-977-5336
    • Michael Bacharach, MD · Principal investigator
    Recruiting
  • VA Tennessee Valley Healthcare System
    Nashville, Tennessee 37212, United States
    Not yet recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
    Recruiting
  • Houston Healthcare
    Houston, Texas 77004, United States
    Recruiting
  • Baylor Scott & White Medical Center
    Plano, Texas 75093, United States
    Recruiting
  • University of Utah Hospital
    Salt Lake City, Utah 84132, United States
    Recruiting
  • Inova Fairfax Medical Campus Inova Health Systems
    Fairfax, Virginia 22031, United States
    Recruiting
  • Sentara Health
    Norfolk, Virginia 23507, United States
    Recruiting
  • University of Washington at Harborview Medical Center
    Seattle, Washington 98104, United States
    • Allison Larimore · Contact · alari@uw.edu
    • Benjamin Starnes, MD · Principal investigator
    Recruiting
  • Bellin Memorial Hospital
    Green Bay, Wisconsin 54301, United States
    Recruiting
  • Prince of Wales Private Hospital- POW Vascular Institute
    Randwick, New South Wales 2031, Australia
    Recruiting
  • Auckland City Hospital
    Auckland, 1023, New Zealand
    • Cynthia Corne · Contact · CorneC@adhb.govt.nz · +64 9 307 4949
    • Andrew Holden, A/Prof · Principal investigator
    Recruiting
08

References and documents

Publications

  • Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):929-935.e1. doi: 10.1016/j.jvs.2023.05.056. Epub 2023 Jun 15. PubMed 37330148 ↗
09

Updates

1 registry update since Sep 25, 2026
Sites
3 sites added. 4 sites changed recruiting status
Show 3 added (3 United States)
  • Ascension Alexian Brothers · Elk Grove, United States
  • VA Tennessee Valley Healthcare System · Nashville, United States
  • Sentara Health · Norfolk, United States
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    3 sites added. 4 sites changed recruiting status
    Show 3 added (3 United States)
    • Ascension Alexian Brothers · Elk Grove, United States
    • VA Tennessee Valley Healthcare System · Nashville, United States
    • Sentara Health · Norfolk, United States
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06001918
Lead sponsor
Nectero Medical, Inc.
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Oct 25, 2023
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Sep 28, 2026

Study contacts

Charlene Knape
Contact
cknape@necteromedical.com
866-755-4744
Tracy Roberts
Contact
troberts@necteromedical.com
(303)3964603
Daniel Clair, MD
principal investigator · Vanderbilt University Medical Center
Grace Wang, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion